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Healey Revision Component System

FDA 510(k)

Class III (US FDA 510(k))

510(k) K921139

by Biomet, Inc.

Identifiers

510(k) Number
K921139 FDA 510(k)
FDA Product Code
JDL FDA 510(k)

Classification

Device Class
Class III FDA 510(k)
Legislation / Framework
21 CFR Part 888.3320 FDA 510(k)
Regulation Number
888.3320 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Healey Revision Component System is a semi-constrained metal cemented acetabular prosthesis designed for hip revision surgery. It is intended to restore hip joint function in patients requiring revision arthroplasty, particularly those with complex acetabular defects or bone loss.

This system is supplied as a reusable orthopedic implant and is regulated under FDA 510(k) clearance (K921139) as a Class III device. It is used in operating room settings and requires sterile handling. Multiple component sizes and configurations are available to accommodate varying anatomical requirements, with regulatory registration numbers including 8043792 and 2242737.

Frequently asked questions

What types of patients is the Healey Revision Component System designed for in hip revision surgery?

The Healey Revision Component System is specifically designed for patients requiring revision arthroplasty of the hip, particularly those with complex acetabular defects or significant bone loss. It is intended to restore hip joint function in cases where standard implants may not provide adequate stability or coverage.

Is the Healey Revision Component System reusable or single-use, and how should it be handled?

The Healey Revision Component System is a reusable orthopedic implant. Since it is used in sterile operating room settings, it must be handled under strict sterile conditions to prevent contamination before and after use.

What range of sizes and configurations are available for the Healey Revision Component System?

The system offers multiple component sizes and configurations to accommodate varying anatomical requirements. While exact dimensions are not specified, the availability of numerous registration numbers (e.g., 8043792, 2242737) suggests a broad range of options to match different patient anatomies and defect severities.

How is the Healey Revision Component System regulated, and what does that mean for its use?

The Healey Revision Component System is regulated under the FDA’s 510(k) clearance process as a Class III device, with the clearance number K921139. This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device, ensuring it meets safety and effectiveness standards for use in hip revision surgeries.

What should clinicians consider when selecting a size or configuration for the Healey Revision Component System?

Clinicians should consider the patient’s specific anatomical requirements, including the extent of acetabular bone loss or defects, as well as the stability needed for the revision. The system’s semi-constrained design and multiple sizes/configurations allow for tailored solutions, but precise sizing should be guided by preoperative imaging and intraoperative assessment to ensure proper fit and function.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HEALEY REVISION COMPONENT SYSTEM (K921139) - FDA 510 (k), HEALEY REVISION COMPONENT SYSTEM (K921139) — FDA 510 (k) | Innolitics, HEALEY REVISION COMPONENT SYSTEM 510(k) K921139 - FDA.report, PDF K921139 - Healey Revision Component System, John H. Healey - Wikipedia

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biomet, Inc.

Sources (1)

  • FDA 510(k) K921139 24 fields · synced Sep 18, 2026